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European Regulatory Affairs Manager

Régió: Budapest

Randstad Hungary Kft.

Hozzáadva: 2017.02.28.
Jelentkezési határidő: 2014.11.13.
Hirdetés azonosító: 838088

European Regulatory Affairs Manager

On behalf of our multinational pharmaceutical partner who is dynamically growing, we are looking for a Regulatory Manager.


Overall responsibility for compiling regulatory submissions to European authorities
PrepaReview regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standardsration and submission of product license applications, variations and renewals

Proactively monitor relevant governmental bodies to identify changes in legislation
Provide regulatory expertise to other departments
Regulatory project management
Supervising packaging material related international operations
Internal liaisoning with Production, QA and Logistics
Correspondance with authorities and suppliers
Reporting of performance indicators
Implementing GMP and GDP requirements in the department
Develop and maintain standard operating procedures and local working practices
Training employees


University degree (preferably in Life Sciences)
Experience in Regulatory in pharmaceutical industry(preferably at least 2 years)
Fluency in English (written and oral, preferably at least at intermediate level)
Fluency in German highly recommendated(written and oral)
Working knowledge of Microsoft Office applications (Word and Excel)
Flexibility and adaptability
Accurate, organized and patient personality
Ability to work well with others

Amit kínálunk:

Competitive salary
Opportunity of continous advancement
Energetic team

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